MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 97800

Device Problem Pocket Stimulation (1463)

Patient Problems Flatus (1865); Undesired Nerve Stimulation (1980); Urinary Frequency (2275); Impaired Healing (2378); Sleep Dysfunction (2517); Paresthesia (4421); Insufficient Information (4580)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.The reason for call was to report that since received implant hasn't experienced any improvement in bladder symptoms during the night and has also noticed a change in their bowel symptoms.Patient said didn't have any issues with bowel movements before the implant.When asked, patient said hasn't made any changes to diet or fluid intake and said is on the same medications as before the implant.Patient also said that the last 4 mornings has been getting up every hour to use the bathroom.Reviewed therapy information and general programming guidance.With instruction, patient connected to implant and made a slight adjustment.Patient will maintain stimulation level and will continue to track symptoms.Patient was redirected to review medical questions with managing physician.Additional information was received from the patient.Patient said their symptom relief was sporadic right now, some mornings were good and they only went a couple times and mornings like this morning they had gone 4-5 times already.Patient said that started around 4-5am and they went every hour from then until 8am.Patient said they also continued to have a bit of change in bowel and said they were very gassy since implant.Patient said their stools were fine and solid but their bm's were not as regular.Patient said sometimes before they're about to urinate, they let out gas.Patient said they had only made one adjustment before and think their ins needs to be adjusted more.Patient services helped patient successfully connect external equipment to ins and patient increased stimulation to a comfortable level.Patient said they could feel a tingling on their left side near where the ins is but it was comfortable.Patient will monitor symptoms.Patient also mentioned it took a while for their scar to heal.Patient said they rarely sleep 4-5 hours through but only need 5 hours of sleep at night.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM X
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18218813
• MDR Text Key: 329144631
• Report Number: 3004209178-2023-23935
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/28/2023
• Date Device Manufactured: 09/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male